Trial Outcomes & Findings for Insul-In This Together Program for Adolescents With Type 1 Diabetes and Their Parents (NCT NCT04589689)

Last Updated: 2025-05-15

Results Overview

Adolescent glucose levels percent time in target range (70-180 mg/dL) based on glucose monitoring to measure glycemic control. The clinical recommendation is a percent time-in-range of 70% or more.

Recruitment status

COMPLETED

Study phase

Target enrollment

366 participants

Primary outcome timeframe

Average percent time in range based on two weeks of glucose monitoring data at baseline, 3-month, and 6-month follow-up (plus or minus 2 weeks around target data collection date)

Results posted on

2025-05-15

Participant Flow

Enrollment was of adolescent/parent dyads, both had to sign informed consent for either of them to enroll, and they received the study intervention together.

366 participants signed informed consent (representing 183 parent-adolescent dyads); 314 participants were randomized to a study arm (representing 157 adolescent-parent dyads).

Participant milestones

Participant milestones
Measure	Intervention Group - Adolescents Group assignment and intervention delivery was based on parent-adolescent dyads. The intervention group were offered the The Insul-In This Together intervention beginning immediately after baseline data collection. The intervention consists of 6 weekly 30-minute online family sessions to discuss topics related to diabetes distress and parent-teen communication, with follow-up visits through 12 months after randomization.	Intervention Group - Parents Group assignment and intervention delivery was based on parent-adolescent dyads. The intervention group were offered the The Insul-In This Together intervention beginning immediately after baseline data collection. The intervention consists of 6 weekly 30-minute online family sessions to discuss topics related to diabetes distress and parent-teen communication, with follow-up visits through 12 months after randomization.	Waitlisted Control Group - Adolescents Group assignment and intervention delivery was based on parent-adolescent dyads. The waitlisted control group were offered the same intervention as the intervention group, beginning after 6-month data collection completion. The intervention consists of 6 weekly 30-minute online family sessions to discuss topics related to diabetes distress and parent-teen communication, with follow-up visits through 12 months after randomization.	Waitlisted Control Group - Parents Group assignment and intervention delivery was based on parent-adolescent dyads. The waitlisted control group were offered the same intervention as the intervention group, beginning after 6-month data collection completion. The intervention consists of 6 weekly 30-minute online family sessions to discuss topics related to diabetes distress and parent-teen communication, with follow-up visits through 12 months after randomization.
Overall Study STARTED	79	79	78	78
Overall Study COMPLETED	68	68	61	61
Overall Study NOT COMPLETED	11	11	17	17

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Insul-In This Together Program for Adolescents With Type 1 Diabetes and Their Parents

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention Group - Adolescents n=79 Participants Group assignment and intervention delivery was based on parent-adolescent dyads. The intervention group were offered the The Insul-In This Together intervention beginning immediately after baseline data collection. The intervention consists of 6 weekly 30-minute online family sessions to discuss topics related to diabetes distress and parent-teen communication, with follow-up visits through 12 months after randomization.	Intervention Group - Parents n=79 Participants Group assignment and intervention delivery was based on parent-adolescent dyads. The intervention group were offered the The Insul-In This Together intervention beginning immediately after baseline data collection. The intervention consists of 6 weekly 30-minute online family sessions to discuss topics related to diabetes distress and parent-teen communication, with follow-up visits through 12 months after randomization.	Waitlisted Control Group - Adolescents n=78 Participants Group assignment and intervention delivery was based on parent-adolescent dyads. The waitlisted control group were offered the same intervention as the intervention group, beginning after 6-month data collection completion. The intervention consists of 6 weekly 30-minute online family sessions to discuss topics related to diabetes distress and parent-teen communication, with follow-up visits through 12 months after randomization.	Waitlisted Control Group - Parents n=78 Participants Group assignment and intervention delivery was based on parent-adolescent dyads. The waitlisted control group were offered the same intervention as the intervention group, beginning after 6-month data collection completion. The intervention consists of 6 weekly 30-minute online family sessions to discuss topics related to diabetes distress and parent-teen communication, with follow-up visits through 12 months after randomization.	Total n=314 Participants Total of all reporting groups
Age, Categorical <=18 years	73 Participants n=5 Participants	0 Participants n=7 Participants	72 Participants n=5 Participants	0 Participants n=4 Participants	145 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants	79 Participants n=7 Participants	6 Participants n=5 Participants	78 Participants n=4 Participants	169 Participants n=21 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Sex/Gender, Customized Male	45 Participants n=5 Participants	7 Participants n=7 Participants	34 Participants n=5 Participants	9 Participants n=4 Participants	95 Participants n=21 Participants
Sex/Gender, Customized Female	32 Participants n=5 Participants	72 Participants n=7 Participants	40 Participants n=5 Participants	68 Participants n=4 Participants	212 Participants n=21 Participants
Sex/Gender, Customized Non-binary	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	3 Participants n=21 Participants
Sex/Gender, Customized Undisclosed	1 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants	0 Participants n=4 Participants	4 Participants n=21 Participants
Race/Ethnicity, Customized Non-Hispanic white	61 Participants n=5 Participants	66 Participants n=7 Participants	61 Participants n=5 Participants	65 Participants n=4 Participants	253 Participants n=21 Participants
Race/Ethnicity, Customized Hispanic white	5 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants	12 Participants n=21 Participants
Race/Ethnicity, Customized Black	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	2 Participants n=4 Participants	8 Participants n=21 Participants
Race/Ethnicity, Customized Asian/Pacific Islander	2 Participants n=5 Participants	4 Participants n=7 Participants	2 Participants n=5 Participants	7 Participants n=4 Participants	15 Participants n=21 Participants
Race/Ethnicity, Customized Native American	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race/Ethnicity, Customized More than once race	7 Participants n=5 Participants	1 Participants n=7 Participants	7 Participants n=5 Participants	0 Participants n=4 Participants	15 Participants n=21 Participants
Race/Ethnicity, Customized Undisclosed	2 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants	1 Participants n=4 Participants	10 Participants n=21 Participants
Region of Enrollment United States	79 Participants n=5 Participants	79 Participants n=7 Participants	78 Participants n=5 Participants	78 Participants n=4 Participants	314 Participants n=21 Participants

PRIMARY outcome

Timeframe: Average percent time in range based on two weeks of glucose monitoring data at baseline, 3-month, and 6-month follow-up (plus or minus 2 weeks around target data collection date)

Population: Enrolled adolescents; data for this outcome were not collected from parents

Adolescent glucose levels percent time in target range (70-180 mg/dL) based on glucose monitoring to measure glycemic control. The clinical recommendation is a percent time-in-range of 70% or more.

Outcome measures

Outcome measures
Measure	Intervention Group n=79 Participants The intervention group were offered the The Insul-In This Together intervention beginning immediately after baseline data collection. The intervention consists of 6 weekly 30-minute online family sessions to discuss topics related to diabetes distress and parent-teen communication, with follow-up visits through 12 months after randomization.	Waitlisted Control Group n=78 Participants The waitlisted control group were offered the same intervention as the intervention group, beginning after 6-month data collection completion. The intervention consists of 6 weekly 30-minute online family sessions to discuss topics related to diabetes distress and parent-teen communication, with follow-up visits through 12 months after randomization.
Glucose Levels Percent Time in Target Range Based on Glucose Monitoring Baseline	61.185 percentage of time-in-range Standard Deviation 18.42	64.542 percentage of time-in-range Standard Deviation 17.74
Glucose Levels Percent Time in Target Range Based on Glucose Monitoring 3 months	62.223 percentage of time-in-range Standard Deviation 18.57	64.571 percentage of time-in-range Standard Deviation 18.21
Glucose Levels Percent Time in Target Range Based on Glucose Monitoring 6 months	61.680 percentage of time-in-range Standard Deviation 18.91	65.908 percentage of time-in-range Standard Deviation 17.82

PRIMARY outcome

Timeframe: Baseline, 3-month follow-up, and 6-month follow-up.

Population: Enrolled adolescents; data for this outcome were not collected from parents

Self-report via Type 1 Diabetes and Life (T1DAL) surveys for adolescents to measure the adolescent's quality of life. Possible score range is 0-100 and the higher scores indicated better quality of life. Adolescent quality of life was measured for adolescents only (not parents).

Outcome measures

Outcome measures
Measure	Intervention Group n=79 Participants The intervention group were offered the The Insul-In This Together intervention beginning immediately after baseline data collection. The intervention consists of 6 weekly 30-minute online family sessions to discuss topics related to diabetes distress and parent-teen communication, with follow-up visits through 12 months after randomization.	Waitlisted Control Group n=78 Participants The waitlisted control group were offered the same intervention as the intervention group, beginning after 6-month data collection completion. The intervention consists of 6 weekly 30-minute online family sessions to discuss topics related to diabetes distress and parent-teen communication, with follow-up visits through 12 months after randomization.
Adolescent Quality of Life Baseline	67.902 score on a scale Standard Deviation 13.92	64.633 score on a scale Standard Deviation 15.38
Adolescent Quality of Life 3-month	67.965 score on a scale Standard Deviation 14.47	63.675 score on a scale Standard Deviation 16.39
Adolescent Quality of Life 6-month	69.523 score on a scale Standard Deviation 14.63	65.511 score on a scale Standard Deviation 16.16

SECONDARY outcome

Timeframe: Baseline, 3-month follow-up, and 6-month follow-up.

Population: Enrolled adolescents; data for this outcome were not collected from parents

Surveys of self-report via Children's Depression Inventory - short version (CDI:S80), a 10 scale item, will be used to assess adolescent depression. Possible total score range is 0-20 with higher scores indicated more severe depressive symptoms. Item response options included 0 = Not at all, 1 = Somewhat, and 2 = A lot. Total score was the sum of all item scores.

Outcome measures

Outcome measures
Measure	Intervention Group n=79 Participants The intervention group were offered the The Insul-In This Together intervention beginning immediately after baseline data collection. The intervention consists of 6 weekly 30-minute online family sessions to discuss topics related to diabetes distress and parent-teen communication, with follow-up visits through 12 months after randomization.	Waitlisted Control Group n=78 Participants The waitlisted control group were offered the same intervention as the intervention group, beginning after 6-month data collection completion. The intervention consists of 6 weekly 30-minute online family sessions to discuss topics related to diabetes distress and parent-teen communication, with follow-up visits through 12 months after randomization.
Adolescent Depression Baseline	2.278 score on a scale Standard Deviation 3.56	2.718 score on a scale Standard Deviation 3.63
Adolescent Depression 3-month follow-up	2.411 score on a scale Standard Deviation 4.27	3.130 score on a scale Standard Deviation 3.91
Adolescent Depression 6-month follow-up	2.419 score on a scale Standard Deviation 4.01	2.963 score on a scale Standard Deviation 3.96

SECONDARY outcome

Timeframe: Baseline, 3-month follow-up, and 6-month follow-up.

Population: Enrolled parents; data for this outcome were not collected from adolescents

Surveys of self-report via the Patient Health Questionnaire (PHQ-8) - 8 item scale to assess depression among parents. Response options for each item included 0 = not at all, 1 = several days, 2 = more than half the days, and 3 = nearly every day. Items were summed into a total score. The possible total score range is 0-24 and higher scores indicate more depressive symptoms.

Outcome measures

Outcome measures
Measure	Intervention Group n=79 Participants The intervention group were offered the The Insul-In This Together intervention beginning immediately after baseline data collection. The intervention consists of 6 weekly 30-minute online family sessions to discuss topics related to diabetes distress and parent-teen communication, with follow-up visits through 12 months after randomization.	Waitlisted Control Group n=78 Participants The waitlisted control group were offered the same intervention as the intervention group, beginning after 6-month data collection completion. The intervention consists of 6 weekly 30-minute online family sessions to discuss topics related to diabetes distress and parent-teen communication, with follow-up visits through 12 months after randomization.
Parent Depression Baseline	4.772 score on a scale Standard Deviation 4.82	5.167 score on a scale Standard Deviation 5.25
Parent Depression 3-month follow-up	4.099 score on a scale Standard Deviation 4.02	4.346 score on a scale Standard Deviation 4.81
Parent Depression 6-month follow-up	4.088 score on a scale Standard Deviation 4.56	4.409 score on a scale Standard Deviation 4.43

SECONDARY outcome

Timeframe: Baseline, 3-month follow-up, and 6-month follow-up

Population: Enrolled adolescents; data for this outcome were not collected from parents

Measured by the Problem Areas In Diabetes (PAID) survey of diabetes distress, which includes 14 items that were summed to create a total score with a possible total score range of 14-84. Item response options range from 1 (not a problem) to 6 (serious problem). Higher scores indicate more diabetes distress.

Outcome measures

Outcome measures
Measure	Intervention Group n=79 Participants The intervention group were offered the The Insul-In This Together intervention beginning immediately after baseline data collection. The intervention consists of 6 weekly 30-minute online family sessions to discuss topics related to diabetes distress and parent-teen communication, with follow-up visits through 12 months after randomization.	Waitlisted Control Group n=78 Participants The waitlisted control group were offered the same intervention as the intervention group, beginning after 6-month data collection completion. The intervention consists of 6 weekly 30-minute online family sessions to discuss topics related to diabetes distress and parent-teen communication, with follow-up visits through 12 months after randomization.
Adolescent Diabetes Distress Baseline	28.608 score on a scale Standard Deviation 12.68	32.064 score on a scale Standard Deviation 14.98
Adolescent Diabetes Distress 3-month follow-up	27.847 score on a scale Standard Deviation 13.07	32.219 score on a scale Standard Deviation 16.39
Adolescent Diabetes Distress 6-month follow-up	27.883 score on a scale Standard Deviation 11.97	30.265 score on a scale Standard Deviation 16.16

SECONDARY outcome

Timeframe: Baseline, 3-month follow-up, and 6-month follow-up.

Population: Enrolled parents; data for this outcome were not collected from adolescents

Measured by the Problem Areas In Diabetes (PAID) survey of diabetes distress, which includes 15 items that were summed into a total score with a possible total score range of 15-90. Higher scores indicate more diabetes distress. Response options ranged from 1 (not a problem) to 6 (serious problem).

Outcome measures

Outcome measures
Measure	Intervention Group n=79 Participants The intervention group were offered the The Insul-In This Together intervention beginning immediately after baseline data collection. The intervention consists of 6 weekly 30-minute online family sessions to discuss topics related to diabetes distress and parent-teen communication, with follow-up visits through 12 months after randomization.	Waitlisted Control Group n=78 Participants The waitlisted control group were offered the same intervention as the intervention group, beginning after 6-month data collection completion. The intervention consists of 6 weekly 30-minute online family sessions to discuss topics related to diabetes distress and parent-teen communication, with follow-up visits through 12 months after randomization.
Parent Diabetes Distress Baseline	43.177 score on a scale Standard Deviation 17.32	44.859 score on a scale Standard Deviation 17.81
Parent Diabetes Distress 3-month follow-up	36.405 score on a scale Standard Deviation 14.27	38.817 score on a scale Standard Deviation 16.22
Parent Diabetes Distress 6-month follow-up	36.393 score on a scale Standard Deviation 14.39	40.542 score on a scale Standard Deviation 18.09

SECONDARY outcome

Timeframe: Baseline, 3-month follow-up, and 6-month follow-up

Population: Enrolled parents; data for this outcome were not collected from adolescents

Surveys of self-report on parenting stress via The Parenting Stress Scale. Includes 18 items that were summed into a total score with a possible total score range from 18-90. Higher scores indicate more parenting stress. Item responses included 1 = strongly agree, 2 = agree, 3 = not sure, 4 = disagree, and 5 = strongly disagree.

Outcome measures

Outcome measures
Measure	Intervention Group n=79 Participants The intervention group were offered the The Insul-In This Together intervention beginning immediately after baseline data collection. The intervention consists of 6 weekly 30-minute online family sessions to discuss topics related to diabetes distress and parent-teen communication, with follow-up visits through 12 months after randomization.	Waitlisted Control Group n=78 Participants The waitlisted control group were offered the same intervention as the intervention group, beginning after 6-month data collection completion. The intervention consists of 6 weekly 30-minute online family sessions to discuss topics related to diabetes distress and parent-teen communication, with follow-up visits through 12 months after randomization.
Parenting Stress Baseline	73.633 score on a scale Standard Deviation 9.73	71.256 score on a scale Standard Deviation 10.88
Parenting Stress 3-month follow-up	74.706 score on a scale Standard Deviation 9.16	71.777 score on a scale Standard Deviation 12.25
Parenting Stress 6-month follow-up	74.376 score on a scale Standard Deviation 9.73	71.865 score on a scale Standard Deviation 10.93

SECONDARY outcome

Timeframe: Baseline and 6-month follow-up

Population: Enrolled adolescents with available data; data for this outcome were not collected from parents

Medical record data on glycated hemoglobin in blood reported as National Glycohemoglobin Standardization Program (NGSP) percentage. The clinical recommendation for pediatrics is below 7.5%.